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Use of pharmacokinetic/ pharmacodynamic modelling for starting dose selection in first-in-human trials of high-risk biologics
AIMS: To illustrate the use of pharmacokinetic–pharmacodynamic (PK–PD) models to select rational starting doses in clinical trials within the minimum anticipated biological effect level (MABEL) principle using literature data and through simulations. METHODS: The new European Medicines Agency guidan...
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Blackwell Science Inc
2009
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| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2670372/ https://ncbi.nlm.nih.gov/pubmed/19076987 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/j.1365-2125.2008.03297.x |
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